Device Classification Name |
tube tracheostomy and tube cuff
|
510(k) Number |
K122932 |
Device Name |
SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT |
Applicant |
FOGLESS INTERNATIONAL AB |
STORGATAN 24 |
VAGGERYD,
SE
56732
|
|
Applicant Contact |
JASON WALTON |
Correspondent |
FOGLESS INTERNATIONAL AB |
STORGATAN 24 |
VAGGERYD,
SE
56732
|
|
Correspondent Contact |
JASON WALTON |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 09/24/2012 |
Decision Date | 12/23/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|